Generic Combination Products: Assessment and Regulatory Update (14of16) GDF 2020

Ashish Rastogi and Steven Hertz from the CDER Office of Pharmaceutical Quality (OPQ) discuss combination product assessments for ANDAs and provide a regulatory update.
Rastogi’s presentation aims to increase transparency in the regulatory process and help applicants understand FDA’s general expectations while preparing quality related sections of ANDA submission for combination products.
Hertz discusses the dynamic global regulatory environment and shares best-practices and lessons learned regarding combination product CGMP and PMSR requirements.
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